Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome

Primary outcomes

1. Change in Bleeding on Probing (BOP%)

   Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

   Dichotomous scoring (yes/no) of bleeding sites on 4 surfaces of teeth.

2. Change in Plaque Control Record (PCR%)

   Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

   % assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.

3. Change in Dental mobility

   Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

   Scoring criteria

   Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; Grade II: horizontal mobility of the tooth from 1 to 2 mm; Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.

4. Change in Modified Gingival Index

   Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

   Scoring criteria (one measurement for each tooth: upper first incisors, first premolars/first primary molars and first molars):

   • Absence of inflammation

   Mild inflammation (marginal or papillary unit) Mild inflammation (entire marginal and papillary unit) Moderate inflammation Severe inflammation

5. Change in compliance

   Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

   Subjective evaluation of the patient's degree of compliance with the proposed treatment by Visual Analogue Scale (VAS), assessing compliance with dosage, alterations and modifications on lifestyle, and adherence to set recalls; to which is associated a score from 0 to 10 of which:

   • 0 to 2: Poor compliance;
   • 3 to 5: Sufficient compliance;
   • 6 to 8: Good compliance;
   • 9 to 10: Excellent compliance.

6. Change in product satisfaction

   Time frame: Baseline (T0), after 1 month (T1), 3 months (T2) and after 6 months (T3)

   • Product liking questionnaire: evaluation of taste, smell, consistency, persistence and ease of application by Visual Analogue Scale (VAS) and filling out a questionnaire to which a score from 0 to 10 is associated, of which:
   • 0: Insufficient;
   • 1 to 3: Sufficient;
   • 4 to 6: Good;
   • 7 to 9: Very Good;
   • 10: Excellent.